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NCT01943851 · BASELINE

Baseline characteristics

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies · Source last updated 2024-10-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      8
    8. group Id
      BG007
      value
      18
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      8
    11. group Id
      BG010
      value
      1
    12. group Id
      BG011
      value
      7
    units
    Participants
groups
  1. description
    Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
    id
    BG000
    title
    Part 1: GSK525762 5 mg QD
  2. description
    Participants were administered once daily oral dose of 10 mg GSK525762.
    id
    BG001
    title
    Part 1: GSK525762 10 mg QD
  3. description
    Participants were administered once daily oral dose of 20 mg GSK525762.
    id
    BG002
    title
    Part 1: GSK525762 20 mg QD
  4. description
    Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
    id
    BG003
    title
    Part 1: GSK525762 30 mg QD MM
  5. description
    Participants were administered once daily oral dose of 40 mg GSK525762.
    id
    BG004
    title
    Part 1: GSK525762 40 mg QD
  6. description
    Participants with MM were administered once daily oral dose of 40 mg GSK525762.
    id
    BG005
    title
    Part 1: GSK525762 40 mg QD MM
  7. description
    Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
    id
    BG006
    title
    Part 1: GSK525762 60 mg QD AML
  8. description
    Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
    id
    BG007
    title
    Part 1: GSK525762 60 mg QD NHL
  9. description
    Participants with MM were administered once daily oral dose of 60 mg GSK525762.
    id
    BG008
    title
    Part 1: GSK525762 60 mg QD MM
  10. description
    Participants with AML were administered once daily oral dose of 75 mg GSK525762.
    id
    BG009
    title
    Part 1: GSK525762 75 mg QD AML
  11. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    BG010
    title
    Part 1: GSK525762 80 mg QD
  12. description
    Participants with AML were administered once daily oral dose of 80 mg GSK525762.
    id
    BG011
    title
    Part 1: GSK525762 80 mg QD AML
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          3
        title
        18-64 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        65-74 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          2
        title
        >74 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          2
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          7
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          4
        title
        Female
      2. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          3
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          1
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          2
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Japanese Heritage(H)/eastAsian (H)/Southeast Asian (H)
      2. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          2
        title
        Black or African american
      3. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Native hawaiian or other pacific islander
      4. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          3
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          8
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          5
        title
        White
      5. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Asian and native hawaiian or other pacific islander
      6. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
NA indicates, Data not presented due to participant confidentiality and privacy concerns
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      8
    8. group Id
      BG007
      value
      18
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      8
    11. group Id
      BG010
      value
      1
    12. group Id
      BG011
      value
      7
    units
    Participants
groups
  1. description
    Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
    id
    BG000
    title
    Part 1: GSK525762 5 mg QD
  2. description
    Participants were administered once daily oral dose of 10 mg GSK525762.
    id
    BG001
    title
    Part 1: GSK525762 10 mg QD
  3. description
    Participants were administered once daily oral dose of 20 mg GSK525762.
    id
    BG002
    title
    Part 1: GSK525762 20 mg QD
  4. description
    Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
    id
    BG003
    title
    Part 1: GSK525762 30 mg QD MM
  5. description
    Participants were administered once daily oral dose of 40 mg GSK525762.
    id
    BG004
    title
    Part 1: GSK525762 40 mg QD
  6. description
    Participants with MM were administered once daily oral dose of 40 mg GSK525762.
    id
    BG005
    title
    Part 1: GSK525762 40 mg QD MM
  7. description
    Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
    id
    BG006
    title
    Part 1: GSK525762 60 mg QD AML
  8. description
    Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
    id
    BG007
    title
    Part 1: GSK525762 60 mg QD NHL
  9. description
    Participants with MM were administered once daily oral dose of 60 mg GSK525762.
    id
    BG008
    title
    Part 1: GSK525762 60 mg QD MM
  10. description
    Participants with AML were administered once daily oral dose of 75 mg GSK525762.
    id
    BG009
    title
    Part 1: GSK525762 75 mg QD AML
  11. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    BG010
    title
    Part 1: GSK525762 80 mg QD
  12. description
    Participants with AML were administered once daily oral dose of 80 mg GSK525762.
    id
    BG011
    title
    Part 1: GSK525762 80 mg QD AML
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          3
        title
        18-64 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        65-74 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          2
        title
        >74 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          2
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          7
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          4
        title
        Female
      2. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          3
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          1
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          2
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Japanese Heritage(H)/eastAsian (H)/Southeast Asian (H)
      2. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          2
        title
        Black or African american
      3. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Native hawaiian or other pacific islander
      4. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          3
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          8
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          5
        title
        White
      5. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Asian and native hawaiian or other pacific islander
      6. measurements
        1. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG000
          value
          NA
        2. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG001
          value
          NA
        3. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG002
          value
          NA
        4. group Id
          BG003
          value
          0
        5. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG004
          value
          NA
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. comment
          Data not presented due to patient confidentiality and privacy concerns
          group Id
          BG010
          value
          NA
        12. group Id
          BG011
          value
          0
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
NA indicates, Data not presented due to participant confidentiality and privacy concerns

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Preserved source evidence · Not medical advice